The bionic pancreas (BP) is initialized with body weight only, makes all insulin dosing decisions autonomously, and uses meal announcements without carbohydrate counting. After completing a Pivotal RCT, 90 of the 107 (aged 6-71) participants who were randomized to the 13-week baseline standard-care (SC) arm in the RCT participated in the 13-week Insulin-Only BP Pivotal Extension Study (ES) . Visit completion rate was 100%. During the baseline SC period, 1 adult participant had 2 severe hypoglycemia (SH) events; the same participant had 2 additional SH events during the ES. During the baseline SC period there were no DKA events; 1 pediatric participant had a DKA event due to infusion set failure during the ES. A decrease of HbA1c, mean CGM glucose, percent of time <70 mg/dl, percent of time >180 mg/dl, and glucose coefficient of variability (CV) , and increased percent of time in range (TIR) occurred in the Extension Study when compared to the baseline SC period. Changes from baseline were similar in adult (N=42) and pediatric (N=48) participants, except for reductions in time <70 mg/dl and CV, which were statistically significant in the pediatric but not adult sub-groups (Table) . The 90 participants who randomized to a 13-week baseline SC period and transitioned to the 13-week ES had statistically significant improvements in HbA1c and CGM outcomes following transition to the Insulin-Only BP without increases in hypoglycemia.
J. L. Lynch: Consultant; Novo Nordisk, Novo Nordisk, Novo Nordisk, Research Support; Beta Bionics, Inc., Beta Bionics, Inc., Beta Bionics, Inc., Jaeb Center for Health Research, Jaeb Center for Health Research, Jaeb Center for Health Research.
Funding from National Institute of Diabetes and Digestive and Kidney Diseases (grant #1UC4DK108612-01) Funding and bionic pancreas devices from Beta Bionics, Inc. Fast-acting insulin aspart and insulin aspart provided by Novo Nordisk Insulin lispro by Eli LillyBlood glucose meters and test strips (Contour?Next One Blood Glucose Monitoring System) provided by Ascensia Diabetes Care, Basel, CH. Continuous glucose monitor sensors and transmitters were purchased from Dexcom, Inc. at a discounted price.